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RecruitingNCT07109505

Nutrition to Support Postoperative Recovery

Comparison of Clinical and Patient Centered Outcomes: Postoperative Multi-nutrient Meal Plus Enhanced Recovery vs. Enhanced Recovery Alone

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Dartmouth-Hitchcock Medical Center · Academic / Other
Sex
All
Age
70 Years
Healthy volunteers
Accepted

Summary

Older surgical patients commonly have malnutrition, and there is evidence these patients have increased risk for poor physical and brain recovery after surgery and anesthesia. There are scientific-based recommendations to provide nutritional supplements to support recovery. However, to date these recommendations do not address a broad group of nutrients likely to reverse common deficiencies. Team members have created a palatable, broad-spectrum and stable nutritional shake that we will give to patients after surgery. We propose to test the nutritional shake in frail older surgical patients at Dartmouth Health to determine if a nutrition shake provided after surgery improves recovery of physical function and cognitive abilities. Half the patients will receive the shake and the other will receive the standard of care postoperative nutritional instructions after surgery. We will collect information regarding physical function and cognitive abilities of all the patients while in the hospital and 90 days after surgery. We will use this data to apply for funding for a powered randomized trial to determine the role of nutrition in optimizing physical and cognitive recovery from surgery in older patients.

Detailed description

We will recruit a cohort of community dwelling patients, age 70 years and older for elective major abdominal and orthopedic surgery. Demographics, medical history, medications will be obtained from the electronic health record and confirmed with the patient. Patients randomized to the nutrition shake arm will receive a provided daily nutritional shake (starting when they leave the hospital and for 1-month after hospital discharge). The shake consists of a comprehensive panel of essential nutrients to support maintenance of muscle, metabolic and brain health.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTNutritional ShakeThe shake mixes will be dry shelf -stable powders prepared with ingredients readily available in the US food supply and contain a minimum of 990 mg total cocoa flavanols, with a profile to support general nutritional health including 10 g protein. Accordingly, each shake contains approximately 95 mg of caffeine, equivalent to a medium-sized cup of coffee. Based on prior studies of cognition, additional composition specifications are: 1600 mg DHA and up to 400 mg EPA and 550 mg choline; \>250 mg epicatechin and epigallocatechin (plant polyphenols); multivitamin/mineral fortification to ensure 50-100% of all essential micronutrients except calcium (to prevent competitive absorption with other divalent cations). Participants will be given a supply of pre-portioned daily servings upon discharge from the hospital, for 30 days after surgery.
OTHERNutritional Instructions OnlyThe control arm receives the Nutrition After Surgery instructions, which provide guidelines for healthy eating after surgery but not the nutritional shake. The intervention arm receives the same instructions along with the nutrition shake mix and accompanying postoperative supplementation

Timeline

Start date
2025-12-10
Primary completion
2026-09-30
Completion
2026-09-30
First posted
2025-08-07
Last updated
2026-02-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07109505. Inclusion in this directory is not an endorsement.